Nonsteroidal immunomodulating agents have been used to relieve inflammation and mild to moderate pain; they are also used for fever and inflammation. Such drugs are usually administered systemically and most often by oral administration. The most common side effect occurring during therapy with certain immunomodulating agents are gastro-intestinal disturbances.
Certain nonsteroidal immunomodulating agents are also available in topical dosage form. Compositions containing nonsteroidal immunomodulating agents for topical treatment of dermatologic and gynecological disorders are available in cream, lotion gel and ointment forms. While semi-solid compositions, such as creams, lotions, gels and ointments are commonly used by consumers, new forms are desirable, in order to achieve better control of the application, while maintaining or bestowing the skin beneficial properties of such products. Thus, the development of new compositions, having breakable foam consistency when released from a container and liquid properties when applied onto the skin is advantageous.
Foams and, in particular, foam emulsions are complicated systems which do not form under all circumstances. Slight shifts in foam emulsion composition, such as by the addition of active ingredients, may destabilize the foam.
There have been a few attempts to create foams including anti-inflammatory agents. U.S. Pat. No. 6,126,920 discloses treatment of various skin diseases, and in particular, scalp psoriasis, using a foamable pharmaceutical composition containing a corticosteroid active substance, an aliphatic alcohol, water, a fatty alcohol, a surface-active agent, a propellant and a buffering agent. The foamable composition contains 40-90% composition of an aliphatic alcohol. Alcohols, and in particular the methyl, ethyl and isopropyl alcohols which are preferred in U.S. Pat. No. 6,126,920, are defatting and irritating agents and may cause skin to become dry and cracked. EP 0535327 B1 discloses a pharmaceutical composition containing (a) 4-biphenylacetic acid (Felbinac); and (b) a carrier which comprises water, ethanol, an aerosol propellant and an ethoxylated stearyl alcohol surfactant. The carrier is adapted to create a quick-break foam. EP 0 270 316 (A3) Patent describes topical compositions including 1-substituted imidazole and non-steroidal anti-inflammatory drugs for treatment of acne. U.S. Pat. No. 6,358,541 teaches preparations for the treatment of androgenetic alopecia comprise saw palmetto berry extract containing phytosterols and one or more low irritability constituents that enhance penetration of the extract into hair follicular pores, e.g., adapalene, tretinoin, retinaldehyde, tazarotene, salicylic acid, azelaic acid, and glycolic acid, wherein the preparation further contains a topical vehicle selected from the group consisting of liquid, gel, foam, styling mousse, styling hair tonic and styling hair spray. U.S. Pat. No. 5,171,577 relates to a process for the preparation of cosmetics or pharmaceutical foam by foaming with the aid of a propellant, the cosmetic or pharmaceutical product includes a dispersion of a water-immiscible phase dispersed in an aqueous medium stabilized with niosomes including one or more layers of a nonionic lipid compound encapsulating an aqueous phase. In certain embodiments, the product may contain at least one product selected from the group consisting of a vitamin, a hormone, an enzyme, a vaccine, an anti-inflammatory agent, an antibiotic, a bactericide, an antifungal agent, an agent to prevent hair loss, an agent to promote hair growth and additional active agents. U.S. Pat. No. 4,981,677 teaches a skin conditioning composition for application to the skin including an oil-in-water emulsion and a propellant including at least 10 percent by weight of petrolatum, at least 50 weight percent of water, an emulsifier having a hydrophilic-lipophilic Balance value of 6 to 10 and a starch or modified starch ester. U.S. Pat. No. 5,002,680 describes a mild skin-cleansing aerosol mousse-forming emulsion including a mild nonsoap anionic or amphoteric surfactant; a polymeric skin feel aid, a moisturizer (preferably glycerin); water; and a propellant. WO 00/15193 teaches a pharmaceutical foam composition including (a) an active ingredient; (b) an occlusive agent; (c) an aqueous solvent; and (d) an organic cosolvent; wherein the active ingredient is insoluble in water and insoluble in both water and the occlusive agent; and wherein there is enough occlusive agent to form an occlusive layer on the skin.